Antiviral composition derived from Allium cepa and therapeutic use thereof

ABSTRACT

Novel medicinal extracts derived from Allium species, preferably  Allium cepa  are provided. These extracts have broad medicinal properties, especially for treatment of ADS and other viral infections.

FIELD OF THE INVENTION

[0001] The invention relates to a novel plant extract and therapeuticuse thereof. More particularly, the present invention relates to the useof a novel plant extract for treating AIDS and other viral infections.

BACKGROUND OF THE INVENTION

[0002] The use of plant derived compositions as therapeutic agents hasbeen known for thousands of years. In particular, the Chinese are knownfor their herbal therapies. Recently, there has been a resurgence in theuse of natural and plant-derived materials that supposedly possesstherapeutic activity and promote general well being. For example, manypersons now take St. John's Wort, purportedly to alleviate depressionand promote general well being. Also, Ginkgo Biloba, purportedly toenhance memory, is widely used now. Further, SAMe, a yeast-derivedmaterial which purportedly is useful for treatment of osteoarthritis andalleviation of depression, is in wide use.

[0003] In particular, the use of materials derived from a plant of theAllium family, especially Allium sativum (“garlic”) has been reported inthe literature. For example, several patents by Tatarintsev et al reportthe use of ajoene compound, derived from the garlic plant, for treatinga variety of ailments including AIDS, inflammation, arthritis,transplant, infection, autoimmune diseases such as lupus, tuberculosis,tumors, and other relates diseases. (See U.S. Pat. Nos. 5,856,363;5,863,955; 5,948,821; and 5,932,621.)

[0004] Also, Hibi, U.S. Pat. No. 5,612,077, describes anajoene-containing extract from garlic for use in treatingarteriosclerosis, tuberculosis, and bronchitis. Further, Tsuei, U.S.Pat. No. 4,795,636; Seebeck, U.S. Pat. No. 2,642,374; and Spinka et al,U.S. Pat. No. 2,618,561, describe garlic extracts as medicinal agents.

[0005] Further, the isolation of compounds from plant materials,including Allium that inhibit apoptosis has been reported. Seeespecially, U.S. Pat. Nos 5,567,425; 5,759,548; 4,986,985; 5,620,885;5,624,672; 5,635,186; and 5,635,187, by Bathurst et al, all of which areincorporated by reference in their entirety herein.

[0006] The foregoing is only exemplary of plant-derived materialsreported to possess medicinal properties. However, notwithstanding thelarge number of plant-derived materials reported to possess therapeuticproperties, there still exists a need for novel plant extracts andtherapeutic use thereof as such therapies may be safer and more costeffective than traditional medical treatments.

OBJECTS OF THE INVENTION

[0007] It is an object of the invention to provide a novel plant extractderived from a plant species of the family Alliaceae (also known asLilliaceae or Amaryllidaceae), preferably of the genus Allium, with theproviso that said Allium is not garlic (Allium sativum), havingmedicinal properties.

[0008] It is a more specific object of the invention to provide novelplant extracts derived from an Allium species selected from the groupconsisting of Allium cepa, Allium ampeloprasum (“leek”), Alliumfistulosa (Japanese bunching onion, scallion or Welsh onion), or Alliumschoenoprasum (“chives”) having medicinal properties.

[0009] It is an even more specific object of the invention to provide anovel plant extract derived from Allium cepa, preferably Allium cepavar. Ancasti or Southporth white glove (SWG) having medicinalproperties.

[0010] It is a more specific object of the invention to provide a novelmethod of treating or preventing a retroviral infection such as HIV-1 orHIV-2 or AIDS by administering a plant extract derived from an Alliumspecies other than Allium sativum, preferably Allium cepa, Alliumfistulosa, Allium ampeloprasum or Allium schoenoprasum, and mostpreferably Allium cepa.

[0011] It is a more specific object of the invention to treat wastingsyndrome, especially associated with AIDS, and/or to lengthen thelatency period of HIV infection, and/or to delay the latent phase ofADS, and/or to ameliorate or eliminate the clinical symptoms associatedwith AIDS such as intestinal problems, diarrhea, neurological impairmentand paresthesia by administering a medicinal extract derived from anAllium species other than Allium sativum, preferably Allium cepa, Alliumfistulosa, Allium ampeloprasum or Allium schoenoprasum, and morepreferably Allium cepa.

[0012] It is another specific object of the invention to inhibit ortreat microbial infection, e.g., fungal, yeast or Candidiasis infectionin a subject in need of such inhibition or treatment, comprisingadministering a medicinal extract derived from an Allium species otherthan A. sativum, preferably Allium cepa, Allium fistulosa, Alliumampeloprasum or Allium schoenoprasum and most preferably Allium cepa.

[0013] It is another specific object of the invention to modulate theimmune system of a subject in need of such treatment, by administering amedicinal extract derived from an Allium species other than Alliumsativum, preferably Allium cepa.

[0014] It is an object of the invention to provide a novel method oftreating or preventing viral infection by administering a medicinalextract derived from an Allium species other than Allium sativum.

[0015] It is a more specific object of the invention to provide a novelmethod of treating or preventing viral infection by administering amedicinal extract derived from an Allium species selected from the groupconsisting of Allium cepa, Allium ampeloprasum, Allium fistulosa, andAllium schoenoprasum.

[0016] It is an even more specific object of the invention to provide anovel method of treating or preventing viral infection by administeringa medicinal extract derived from Allium cepa, preferably the varietyAncasti or Southporth white glove.

[0017] It is another object of the invention to immunostimulate theimmune system of a subject in need of such treatment by administering amedicinal extract derived from an Allium species other than sativum,preferably Allium cepa, Allium fistulosa, Allium schoenoprasum or Alliumampeloprasum and more preferably Allium cepa.

[0018] It is another object of the invention to enhance T cell functionand/or T cell proliferation, and/or T-cell differentiation, byadministering a medicinal extract derived from an Allium species otherthan Allium sativum, preferably Allium cepa, Allium fistulosa, Alliumschoenoprasum or Allium ampeloprasum, most preferably Allium cepa.

[0019] It is another specific object of the invention to identify andisolate the active constituent or constituents comprised in the Alliumextract disclosed herein having antimicrobial, antifungal, antiviral,immunomodulatory, T cell function or proliferation inducing, and/orimmunostimulatory activity.

[0020] It is another specific object of the invention to promote weightgain in a subject in need of such treatment by administering aneffective amount of a medicinal extract derived from an Allium selectedfrom Allium cepa, Allium fistulosa, Allium schoenoprasum or Alliumampeloprasum, most preferably Allium cepa.

[0021] It is another object of the invention to treat animal microbialinfections, especially viral infections such as distemper or parvovirusor bacterial infections such as psittacosis, by administering amedicinal extract derived from Allium cepa.

[0022] It is another object of the invention to provide a method forproducing a medicinal extract from Allium species selected from Alliumcepa, Allium fistulosa, Allium schoenoprasum or Allium ampeloprasum.

[0023] It is another object of the invention to provide a novelmedicinal extract derived from Allium cepa, Allium fistulosa, Alliumschoenoprasum, or Allium ampeloprasum, preferably orally administrable.

[0024] It is another specific object of the invention to provide a novelregimen for treating AIDS that includes a dietary regimen, noadministration of conventional AIDS medications such as proteaseinhibitors, anti-retrovirals, or other chemotherapeutics causingmultiple side effects (other than antibiotics) and administration of amedicament derived from a plant of the genus Allium, preferably Alliumcepa.

DETAILED DESCRIPTION OF THE INVENTION

[0025] The present invention is based on the discovery that plants ofthe family Alliaceae, specifically those of the genus Allium, includingAllium cepa, and related species such as Allium fistulosa, Alliumschoenoprasum, and Allium ampeloprasum, can be used to obtain plantextracts having significant medicinal properties. In particular, it hasbeen surprisingly discovered that extracts derived from Allium species,preferably Allium cepa, have wide ranging medicinal properties,including antiviral activity, antimicrobial activity (antifungal,antibacterial), immunomodulating activity, immunostimulating activity,T-cell function and/or T-cell proliferation and/or T-celldifferentiation enhancing activity, and weight gain promoting activity.

[0026] This discovery is surprising in the fact that onions, whileanecdotally reported to possess some medicinal properties, e.g.,inhibition of thrombocyte aggregation and lipid and blood pressurelowering activity, have never been suggested to possess the wide rangingmedicinal activities discovered by the present inventors, especiallyregarding AIDS.

[0027] Therefore, the subject invention provides novel medicinalextracts and methods of use thereof, wherein such medicinal extracts arederived from a plant of the family Alliaceae (also known as Liliaceae orAmaryllidaceae), preferably Allium but excluding Allium sativum, andpreferably Allium cepa, Allium fistulosa, Allium schoenoprasum or Alliumampeloprasum. Most preferably, the novel medicinal extracts of thepresent invention will be derived from onion (Allium cepa L.).

[0028] The onion, Allium cepa L. (2n=16 diploid), is a monocotyledon ofthe family Alliaceae which is by far the most economically importantbulb vegetable. It is thought that the onion originated in Persia(Nonnecke, Ill., “Vegetable Production”, Van Nostrand Reinhold, N.Y.(1989)) cultivated by the Egyptians, Greeks and Romans and brought toNorth America by the Spaniards. The onion has long been considered topossess medicinal value (Nonnecke (Id.)).

[0029]Allium cepa is divided into three main groups.

[0030] 1. The common onion—bulbs are formed as single plants, and theinflorescence does not form bulbets (Nonnecke, (Id.)1989). The bulk ofthe onion cultivars belong to this group, which is the most importantcommercially (Nonnecke, (Id.)1989). It is propagated in the main fromtrue seeds. Within this group exist extremes of bulb shapes (present-daycultivars include the Sweet Spanish, Bermuda, and globe onions), dryscale color (white, yellow, and red predominating), pungency (rangingfrom mild and sweet to pungent), and other characteristics (Nonnecke,(Id.)1989). When harvested early they produce spring or bunching onions(Lorenz, Onion, In “The Software Toolworks Multimedia Encyclopedia”,Version 1.5, Grolier, Inc. (1992)). The onion plant is potentially abiennial, producing large bulbs the first year and seed the next(Lorenz, (Id.)1992). Plants may be grown from seed, as transplants ofseedlings, or as small bulbs (sets) produced from thickly planted seed;when replanted, these bulbs reach maturity rapidly (Lorenz, (Id.)1992).Mature onions are usually dried before marketing (Lorenz, (Id.)1992).

[0031] 2. The aggregatum group—characterized by many lateral bulbs orshoots, inflorescences lacking bulbets, sterile seed production, andpropagation by vegetative means (Nonnecke, (Id.)1989). This groupincludes the potato onion or multiplier onion, ever-ready onions, andshallots (shallots are sometimes called scallions, a source of confusionbecause A. fistulosum is also called scallions) (Nonnecke, (Id.)1989).

[0032] 3. The proliferous (proliferum) group—in this group, ground bulbsare sometimes poorly developed, the inflorescence bears bulbets, trueseed is usually lacking, and therefore reproduction is by vegetativeinflorescence and bulbets (Nonnecke, (Id.)1989). These are notcommercially cultivated; they are used almost exclusively for homegardening (Nonnecke, (Id.)1989). The most common names for this groupare tree onions, top-set onions, and Egyptian onions (Nonnecke,(Id.)1989).

[0033] The common onion (1. above), is a herbaceous biennial normallyproducing seed stems in the form of an umbel consisting of florets(Nonnecke, (Id.)1989). The swollen base of the stem forms a bulb made upof numerous fleshy leaves (Nonnecke, (Id.)1989). Short day lengthvarieties are adapted for use in areas south of 30° N (Nonnecke,(Id.)1989). Medium day length varieties are adapted to mild areas from30° N to about 38° N, in areas where comparatively mild winters occur:south to central California, Georgia and mid-Atlantic states (Nonnecke,(Id.)1989). The long day onions are adapted for spring seeding ortransplanting in sites north of 38° N (Nonnecke, (Id.)1989). The longerday length compensates for the shortness of the growing season byproviding longer periods of photosynthetic activity (Nonnecke,(Id.)1989). It is absolutely critical to choose the appropriate cultivarfor the appropriate environment; when short-day cultivars are grown in along-day growing area or vice versa, the onion will not perform asexpected Nonnecke, (Id.)1989).

[0034] Onions for dehydration are white and have high soluble solids(Nonnecke, (Id.)1989). They are grown mostly in California where thelong growing season permits the right balance of solids and pungencydesired for the dehydrated product (Nonnecke, (Id.) 1989). The Americanmarket classifies onions according to maturation time (Nonnecke,(Id.)1989). The Bermuda Granex, a grano type that is mild and flat topshaped, is an early-maturing onion with little or no storage life(Nonnecke, (Id.)1989). The late crop onions, mostly globe shaped withyellow, white or red scales are mild or pungent depending on cultivarand environment, and usually store well over long periods (Nonnecke,(Id.)1989). The bulk of the seed is produced in an environment conduciveto good seed set, such as California (Nonnecke, (Id.)1989).

[0035] In general, the medicament of the present invention which isderived from Allium cepa, Allium fistulosa, Allium schoenoprasum orAllium ampeloprasum, and preferably Allium cepa, more preferably typeAncasti and Southporth white glove, is produced by dehydration of anAllium plant material other than Allium Sativum by one or more heatingsteps, typically effected at about 80° C./110° C. or higher, i.e., afteran initial washing procedure, removal of non-viable materials andremoval of other impurities such as stones, wires, etc., and processingof the dehydrated material into fine particles or granules, i.e.,roughly having the consistency of talcum powder or confectionary sugar,such that the average particle size ranges from about 1 to 1,400 micronsand, more preferably, ranges from about <250 to about 850 microns. Thisgranulation or particulation procedure can be effected or knownindustrial devices for effecting granulation, or in particular by use ofhigh speed cutters such as those available from Moulinex or othersuppliers. Such granulation will preferably be effected at low humidity,e.g., ≦5%-7% humidity, in order to prevent aggregation or clumping ofparticles or granules during processing. It is hypothesized by thepresent inventors that the particulate size of the subject medicamentmay enhance its medicament properties, perhaps because of increasedsurface area. Alternatively, it is speculated that particles of suchsize may facilitate absorption or uptake of the active constituent byspecific cells, e.g., immune cells, and thereby potentiate its effect onthe immune system.

[0036] Preferably, the utilized procedure for particulating theprocessed dehydrated Allium, preferably Allium cepa, material willresult in most (greater than 95%) of the particles or granules in theresultant composition having an average size ranging from 1 to 1,400microns, more preferably most of the particles will have an averageparticle size in the range of ≦10 microns to about 850 microns, and mostpreferably most of the particles will have an average size within therange of 36 to 500 microns.

[0037] A preferred procedure for producing an Allium medicinal extractaccording to the invention comprises the following steps. This processis exemplary of the processes that can be used to produce the novelmedicinal extract of the invention. Indeed, it is anticipated that theordinary routineer will be able to modify this procedure without adverseeffects, e.g., to reduce costs and enhance efficacy.

[0038] In the exemplary process, an Allium plant material, preferablyAllium cepa, Allium fistulosa, Allium ampeloprasum or Alliumschoenoprasum, preferably Allium cepa, including at least the bulbportion of the plant, is obtained. In a preferred embodiment, theselected Allium cepa material will comprise Allium cepa variety ancastior Southporth white glove. However, this is not essential to theinvention, and other Allium cepa varieties may alternatively beutilized. Preferably, the selected Allium cepa or above-identifiedAllium species will be grown in the absence of herbicides, insecticidesand other agrochemicals such as organic fertilizers. However, this alsois not essential to the invention.

[0039] This Allium plant material, which includes especially the bulbportion of the plant, may be stored prior to medicament preparation,preferably under cold conditions, typically about 10° C. at 70%humidity, or about 5-15° C. at 60-80% humidity. For example, the Alliumplant material may be stored in wooden boxes (bines) for prolongedperiod, e.g., at least 30 days, and up to about 4 months. If stored forlonger periods, the active constituents may lose their activity, e.g.,because of natural decomposition of the onion over time.

[0040] Thereafter, the Allium plant material containing the bulbportion, optionally after it has been stored under appropriateconditions undergoes a quality evaluation. This material may also beclassified based on size of plant materials.

[0041] Thereafter, the plant material is subjected to one or morewashing procedures. Preferably, this washing will be effected underabrasive conditions on a conveyor belt which comprises use of an acidicaqueous washing solution, preferably a chlorinated aqueous solution. Ina preferred embodiment, the washing solution will contain about 100 to120 parts per million of chlorine. Preferably, no other chemicaladditives will be utilized during the washing procedure to eliminatefungus or bacteria. As noted, the washing is effected under abrasiveconditions, i.e., the bulbs are also treated by abrasion, e.g., by abrushing procedure, at this time to remove the outer layers. Thereafter,one or more additional washing steps are then preferably effected, againusing a chlorine-containing aqueous washing solution, preferably a coldchlorine-containing aqueous solution.

[0042] More specifically, the subject medicament is produced using anindustrial process that complies with the F.D.A. regulations of theU.S.A. under the quality ISO 9000 norms. Preferably, the bulbrecollection is industrial, not manual. After collection, the bulbs arepreferably stored in wooden boxes of 1m×1m×1m called bines. To maintainstability, such bulbs are stored in chambers at an average of 10° C. at70% humidity (5-15° C. and 60-80% humidity.) The normal storage doesrange between 30 and 120 days. This is followed by a quality evaluation(defects, solid material content, etc.). The optionally sorted bulbs arethen sent to the elaboration plant.

[0043] The vegetal material is loaded in a large recipient or feeder totransport the material by a conveyor belt to start the first step in theprocess. In one embodiment the conveyor belt is made of a sequence ofcylinders with brushes upon which the vegetal material rolls.Thereafter, “washing by abrasion” is effected with cold chlorinatedwater (e.g., about 7 to 15° C.). The chlorine concentration preferablyranges from 100 to 120 parts per million. No additive is used toeliminate fungus and bacteria. The bulbs are also brushed to eliminatethe outer layers. This process of washing by abrasion is repeated asecond time under identical conditions.

[0044] A belt is then used to transport the bulbs to the place where thematerial is sorted, e.g., manually, by discarding the non-viable one(e.g., green non-comestible or rotten material.) Thereafter, thematerial goes through a process of decantation eliminating foreignbodies such as stones, wires, etc. The bulbs are then cut into thinslices (e.g. 2-7 mm), preferably about 2-4 mm., e.g., by use of acutting machine, to help the process of selection and dehydration. Thisis followed by the process of dehydration. For example, in oneembodiment, the material is transported using another belt, and thetransported material is preferably then heated, e.g. in an oven of drycontinuous heat, and preferably first at 80-100° C. for 45 minutes,followed by 90-110° C. for another 45 minutes, and finally dehydrationis completed at 80-100° C. for 30 minutes. This final material (calledvirgin) contain 5-7% humidity. However, it is anticipated that theheating process may be varied without adverse effects.

[0045] The virgin is kept in sealed bags at 20 to 25° C., preferablyunder dark conditions, until it will be needed. When needed for use, the“virgin” material is then processed with another machine that strips theouter layers and leaves the pulp by pneumatic separation. In this way,the slices obtained are of pulp material. This pulp is then chopped intoflakes, which preferably are kept sealed at 18-25° C., away fromsunlight.

[0046] After drying, the plant material, which consists of the pulp (andoptionally outer layers) is then loaded into an industrial processingdevice, e.g., high speed cutters. Other option is the use of devicessuch as “Moulinex”, or from other suppliers, that processes thismaterial into fine particles or granules.

[0047] Preferably this granulation is effected at very low humidity,i.e., maximum of about 5.5% humidity to avoid clumping, in order toprovide granulates having an average particle size ranging from about 1to 1,400 microns, more preferably from about ≦36 microns to 850 microns.The dried particles will typically comprise at most 5.5% water, andpreferably less. In an exemplary composition produced according to theinvention from Allium cepa, about 42.9% of particles were smaller than250 microns, 56.9% were less than 355 microns, 74.7% were less than 500microns, and 2f.7% were between 500-850 microns, with 22.1% ranging from106-250 microns, 6.8% ranging from 75-106 microns, 10.8% ranging in sizefrom 36-75 microns, and 3.2% being <36 microns. Thus, the significantmajority of particles are less than 500 microns, with most ranging from<36 to 850 microns.

[0048] The dried particulate material may be immediately used as amedicament or it may be stored for a prolonged time prior to usage. Thismaterial preferably will be stored under cold (typically about 18 to 25°C.), dark conditions, for up to a year or even longer. This will preventdegradation of active constituents, e.g., by oxidation or sunlight.

[0049] It is believed that the subject treatment process whichessentially comprises acidic washing steps, heated dehydration, andgranulation into very fine particles having the consistency of a finepowder, e.g., on the order of talcum powder, results in an extracthaving a substantially unchanged chemical composition from the originalAllium material, except for the removal of water, scent, and some othervolatile acids.

[0050] However, the present inventors do not rule out the possibilitythat the washing, dehydration process and the heating steps used in thesubject matter may be facilitating one or more reactions that result inthe formation of one or more medicament compounds that are notendogenously present in Allium or which were present in lowerconcentrations, may provide for the release of larger amounts of activeconstituents. With respect thereto, the subject inventors are uncertainas to what are the exact active constituent or constituents that arecontained in the subject medicament composition.

[0051] However, it has been reported that Allium cepa comprises thecompounds listed below.

[0052] 1-(F)-β-FRUCTOSYL-SUCROSE

[0053] 1-(METILSULFINYL)-PROPYL-METHYL-DISULFIDE

[0054] 1-METHYLDITHIO-PROPANE

[0055] 1-METHYLTRITHIO-PROPANE

[0056] 1-0-CAFFEOYL-β-D-GLUCOSE

[0057] 1-0-FERULOYL-β-D-GLUCOSE

[0058] 1-0-P-COUMAROYL-β-D-GLUCOSE

[0059] 1-PROPYLTRlTHOPROPANE

[0060] 2,3-DIMETHYL-(D,L)-BUTANE-CIS-1-CIS-D-S,S′-DIOXIDE

[0061] 2,3-DIMETHYL-5,6-DITHIA-BICYCLO-(2,2,1)-HEXANE-5-OXIDE

[0062] 2,3-DIMETHYLTHIOPHENE

[0063] 2,4-DIMETHYLTHIOPHENE

[0064] 2,5-DIMETHYLTHIOPHENE

[0065] 24-METHYLENE-CYCLOARTENOL

[0066] 28-ISOFUCOSTEROL

[0067] 2-METHYL-BUT-2-EN-1-AL

[0068] 2-METHYL-BUTANAL

[0069] 2-METHYL-BUTYR-2-ALDEHYDE

[0070] 2-METHYL-PENT-2-EN-1-AL

[0071] 2-METHYL-PENTANAL

[0072] 3,4-DIMETHYL-2,5-DIOXO-2,5-DIHYDROTHIOPHENE

[0073] 3,4-DIMETHYLTHIOPHENE

[0074] 31-NORCYCLOARTENOL

[0075] 31-NORLANOSTENOL

[0076] 4-α-METHYL-ZIMOSTENOL

[0077] 5-DEHYDRO-AVENASTEROL

[0078] 5-HEXYL-CYCLOPENTA-1,3-DIONE

[0079] 5-METHYL-2-n-HEXYL-2,3-DIHYDROFURAN-3-ONE

[0080] 5-OCTYL-CYCLOPENTA-1,3-DIONE

[0081] 6(G)-β-FRUCTOSYL-SUCROSE

[0082] 9,10,13-TRIHYDROXY-OCTADEC-11-ENOIC-ACID

[0083] 9,12,13-TRIHYDROXY-OCTADEC-10-ENOIC-ACID

[0084] ABSCISSIC-ACID

[0085] ACETAL

[0086] ACETIC-ACID

[0087] ALANINE

[0088] ALLICIN

[0089] ALLIIN

[0090] ALLIOFUROSIDE-A

[0091] ALLIOSPIROSIDE-A

[0092] ALLIOSPIROSIDE-B

[0093] ALLIOSPIROSIDE-C

[0094] ALLIOSPIROSIDE-D

[0095] ALLYL PROPYL SULFIDE

[0096] ALLYL PROPYL TRISULFIDE

[0097] ALLYL-METHYL-DISULFIDE

[0098] ALLYL-METHYL-SULFIDE

[0099] ALLYL-METHYL-TRISULFIDE

[0100] ALLYL-PROPENYL-DISULFIDE

[0101] ALLYL-PROPYL-DISULFIDE

[0102] ALLYLTHIOL

[0103] ALUMINUM

[0104] AMMONIA

[0105] ARABINOSE

[0106] ARACHIDIC-ACID

[0107] ARGININE

[0108] ARSENIC

[0109] ASCORBIC-ACID

[0110] ASH

[0111] ASPARAGINE

[0112] ASPARTIC-ACID

[0113] BARIUM

[0114] BENZYL ISOTHIOCIANATE

[0115] BORON

[0116] BRASSICASTEROL

[0117] BROMINE

[0118] CADMIUM

[0119] CAFFEIC-ACID

[0120] CALCIUM

[0121] CALCIUM-OXALATE

[0122] CAMPHESTEROL

[0123] CARBOHYDRATES

[0124] CATECHOL

[0125] CEPAENES

[0126] CEPOSIDE-D

[0127] CHOLEST-7-EN-3-β-OL

[0128] CHOLESTEROL

[0129] CHOLINE

[0130] CHROMIUM

[0131] CIS-1-(PROPENYL-DITHIO)-PROPANE

[0132] CIS-2,3-DIMETHYL-5,6-DITHIO-CYCLO(2,2,1)HEPTANE-5-OXIDE

[0133] CIS-3,5-DIETHYL-1,2,4-TRITHOLANE

[0134] CIS-PROPANETHIOL-S-OXIDE

[0135] CIS-PROPENYL-PROPYL-DISULFIDE

[0136] CIS-PROPENYL-PROPYL-TRISULFIDE

[0137] CITOSINE

[0138] CITRIC-ACID

[0139] CITRULINE

[0140] COBALT

[0141] COPPER

[0142] CYANIDIN-3-0-LAMINARIBIOSIDE

[0143] CYANIDIN-3-0-β-D-DIGLYCOSIDE

[0144] CYANIDIN-BIOSIDE

[0145] CYANIDIN-DIGLYCOSIDE

[0146] CYANIDIN-MONOGLYCOSIDE

[0147] CYCLOALLIIN

[0148] CYCLOARTENOL

[0149] CYCLOEUCALENOL

[0150] CYSTEINE

[0151] CYSTINE

[0152] DIALLYL-DISULFIDE

[0153] DIALLYL-SULFIDE

[0154] DIALLYL-TRISULFIDE

[0155] DIHYDROALLIIN

[0156] DIISOPROPYL-TRISULFIDE

[0157] DIMETHYL-DISULFIDE

[0158] DIMETHYL-FURANE

[0159] DIMETHYL-SULFIDE

[0160] DIMETHYL-TETRASULFIDE

[0161] DIMETHYL-TRISULFIDE

[0162] DIMETHYL-TRISULFIDE

[0163] DIPHENYLAMINE

[0164] DIPROPENYL-DISULFIDE

[0165] DIPROPENYL-SULFIDE

[0166] DIPROPYL-DISULFIDE

[0167] DIPROPYL-TRISULFIDE

[0168] D-MANNITOL

[0169] EICOSEN-1-OL

[0170] EO

[0171] ETHANOL

[0172] ETHANOLAMINE

[0173] FATS

[0174] FERULIC-ACID

[0175] FIBER

[0176] FLUORINE

[0177] FRUCTOSAN

[0178] FRUCTOSE

[0179] FUMARIC-ACID

[0180] GIBERELLIN-A-4

[0181] GLUCINE

[0182] GLUCOFRUCTAN

[0183] GLUCOSE

[0184] GLUTAMINE

[0185] GLUTAN

[0186] GLYCINE

[0187] GLYCOLIC-ACID

[0188] GRAMISTEROL

[0189] HEXADECEN-1-OL

[0190] HISTIDINE

[0191] HYDROGEN SULFUR

[0192] IRON

[0193] ISOLEUCINE

[0194] ISOPROPYL-PROPYL-DISULFIDE

[0195] ISOPROPYL-PROPYL-TRISULFIDE

[0196] KAEMPFEROL

[0197] KAEMPFEROL-3,4′-DI-0-β-D-GLUCOSIDE

[0198] KAEMPFEROL4′,7-DI-0-β-D-GLUCOSIDE

[0199] KAEMPFEROL-4′-O-β-D-GLUCOSIDE

[0200] LEAD

[0201] LEUCINE

[0202] LINOLEIC-ACID

[0203] LITHYUM

[0204] LOPHENOL

[0205] LYSINE

[0206] MAGNESIUM

[0207] MALIC-ACID

[0208] MANGANESE

[0209] MERCURY

[0210] METHANOL

[0211] METHANOTHIOL

[0212] METHIONINE

[0213] METHIONINE-METHYLSULFONIUM

[0214] METHIONINE-SULFONE

[0215] METHYL-ALLIIN

[0216] METHYL-CIS-PROPENYL-DISULFIDE

[0217] METHYL-DITHIOMETHANE

[0218] METHYL-METHANOTHIOSULFONIUM

[0219] METHYL-PROPENYL-SULFIDE

[0220] METHYL-PROPENYL-TRISULFIDE

[0221] METHYL-PROPYL-DISULFIDE

[0222] METHYL-PROPYL-TRISULFIDE

[0223] METHYL-TRANS-PROPENYL-DISULFIDE

[0224] MEVALONIC-ACID

[0225] MOLYBDENUM

[0226] MUFA

[0227] MYRISTIC-ACID

[0228] MYROSINASE

[0229] NIACIN

[0230] NICKEL

[0231] NITROGEN

[0232] NONADECANOIC-ACID

[0233] N-PROPYL-MERCAPTAN

[0234] OLEANOLIC-ACID

[0235] OLEIC-ACID

[0236] OXALIC-ACID

[0237] PAEONIDIN-GLYCOSIDE

[0238] PALMITIC-ACID

[0239] PANTOTHENIC-ACID

[0240] P-COUMARIC-ACID

[0241] PECTIN

[0242] PELARGONIDIN-MONOGLYCOSIDE

[0243] PENTOSAN

[0244] PEROXIDASE

[0245] PHENILALANINE

[0246] PBLOROGLUCINOL

[0247] PHLOROGLUCYOL-CARBOXYLIC-ACID

[0248] PHOSPHORUS

[0249] P-HYDROXYBENZOIC-ACID

[0250] PHYROCATECOL

[0251] PHYTOHORMONE

[0252] PHYTOSTEROLS

[0253] PIPECOLIC-ACID

[0254] POTASSIUM

[0255] PROLINE

[0256] PROPAN-1-OL

[0257] PROPANAL

[0258] PROPANALDEHYDE

[0259] PROPANE-1-THIOL

[0260] PROP-CIS-ENYL-PROPYL-DISULFIDE

[0261] PROP-CIS-ENYL-PROPYL-TRISULFIDE

[0262] PROPENE

[0263] PROPENYL-PROPYL-SULFIDE

[0264] PROP-TRANS-ENYL-PROPYL-DISULFIDE

[0265] PROP-TRANS-ENYL-PROPYL-TRISULFIDE

[0266] PROPYL-METHANOTHIOSULFONATE

[0267] PROPYL-PROPANOTHIOSULFONATE

[0268] PROSTAGLANDIN-A-1

[0269] PROTEIN

[0270] PROTOCATECHUIC-ACID

[0271] PUFA

[0272] PYRUVIC-ACID

[0273] QUERCETIN

[0274] QUERCETIN-3,4′-DI-0-β-D-GLUCOSIDE

[0275] QUERCETIN-3-0-β-D-GLUCOSIDE

[0276] QUERCETIN-4′,7-DI-0-P-D-GLUCOSIDE

[0277] QUERCETIN-4-0-β-D-GLUCOSIDE

[0278] QUINIC-ACID

[0279] RAFFINOSE

[0280] RHAMNOSE

[0281] RIBOFLAVIN

[0282] RIBOSE

[0283] RUBIDIUM

[0284] RUTIN

[0285] S-(2-CARBOXY-PROPYL)-GLUTATHIONE

[0286] S-(β-CARBOXYBETA-METHYL-ETHER-CISTEINE

[0287] S-ALLIL-CYSTEINE

[0288] SAPONIN

[0289] SELENIUM

[0290] SELENO-CYSTEINE

[0291] SELENO-METHIONINE

[0292] SELENO-METHYLSELENOCYSTEINE

[0293] SELENO-METHYL-SELENOMETHIONINE

[0294] SELENOSIDE

[0295] SERINE

[0296] SFA

[0297] SILICON

[0298] SILVER

[0299] SINAPIC-ACID

[0300] S-METHYL-CYSTEINE

[0301] S-METHYL-CYSTEINE-SULFOXIDE

[0302] SODIUM

[0303] SPIRAEOSIDE

[0304] S-PROP-1-ENYL-CYSTEINE-S-OXIDE

[0305] S-PROPYL-1-ENYL CYSTEINESULFOXIDE

[0306] S-PROPYL-CYSTEINE-SULFOXIDE

[0307] STEARIC-ACID

[0308] STIGMAST-7-EN-3-β-OL

[0309] STIGMASTEROL

[0310] STRONTIUM

[0311] SUCCINIC-ACID

[0312] SUCROSE

[0313] SULFUR

[0314] TARTARIC-ACID

[0315] THIAMIN

[0316] THIOPROPANAL-S-OXIDE

[0317] THIOPROPIONAL-S-OXIDE

[0318] TITANIUM

[0319] TRANS-1-(PROPENYL-DITHIO)-PROPANE

[0320] TRANS-2,3-DIMETHYL-5,6-DITHIA-CYCLO-(2,2,1)-HEPTANE-5-OXIDE

[0321] TRANS-3,5-DIETHYL-1,2,4-TRITHIOLANE

[0322] TRANS-PROPENYL-PROPYL-DISULFIDE

[0323] TRANS-PROPENYL-PROPYL-TRISULFIDE

[0324] TRANS-S-(1-PROPENYL)-CYSTEINE-SULFOXIDE

[0325] TREONINE

[0326] TREDECAN-2-ONA

[0327] TRIGONELLINE

[0328] TRYPTOPHAN

[0329] TSEPOSIDES

[0330] TULIPOSIDE-A

[0331] TULIPOSIDE-B

[0332] TYROSINE

[0333] VALINE

[0334] VANILLIC-ACID

[0335] VIT-B-6

[0336] WATER

[0337] XYLITOL

[0338] XYLOSE

[0339] ZINC

[0340] ZIRCONIUM

[0341] α-AMYRIN

[0342] α-SITOSTEROL

[0343] α-TOCOPHEROL

[0344] β-ALALNINE

[0345] β-CAROTENE

[0346] β-SITOSTEROL

[0347] β-TOCOPHEROL

[0348] γ-ABULINE

[0349] γ-AMINOBUTIRIC-ACID

[0350] γ-GLUTAMYL-LEUCINE

[0351] γ-GLUTAMYL-METHIONINE

[0352] γ-GLUTAMYL-PHENYLALANINE

[0353] γ-GLUTAMYL-PHENYLALANINE-ETHYL-ESTER

[0354] γ-GLUTAMYL-S-METHYL-CYSTEINE

[0355] γ-L-GLUTAMYL-ARGININE

[0356] γ-L-GLUTAMYL-CYSTEINE

[0357] γ-L-GLUTAMYL-ISOLEUCINE

[0358] γ-L-GLUTAMYL-S-(1-PROPENYL)L-CYSTEINE-SULFOXIDE

[0359] γ-L-GLUTAMYL-S(2-CARBOXY-N-PROPYL)L-CISTEINE

[0360] γ-L-GLUTAMYL-S-(2-CARBOXY-β-METHYL-ETHYL)-CYSTEINYL-GLY

[0361] γ-L-GLUTAMYL-S-(2-CARBOXY-β-METHYL-ETHYL)-CYSTEINYL-GLY

[0362] γ-L-GLUTAMYL-VALINE

[0363] CYANIDIN-3-MALONYLGLUCOSIDE

[0364] CYANIDIN-3-MANOLYLAMINARIBIOSIDE

[0365] PEONIDIN-3-GLUCOSIDE

[0366] PEONIDIN-3-MALONYLGLUCOSIDE

[0367] PHOSPHATASE

[0368] PROPILENSULFIDE

[0369] QUERCETIN-3,4′-O-β-DIGLUCOPYAOSIDE

[0370] QUERCETIN-3,7,4′-O-β-GLUCOPYRANOSIDE

[0371] QUERCETIN-4′-O-β-GLUCOPYRANOSIDE

[0372] TAXIFOLIN-4′-O-b-GLUCOPYRANOSIDE

[0373] β-FRUCTOFURANOSIDASE

[0374] γ-GLUTAMYLTRANSPEPTIDASE

[0375] Of the above materials, those that are especially hypothesized tobe responsible for the medicinal and immune regulating activity of thesubject Allium extract are set forth below.

[0376] 1-O-CAFFEOYL-b-D-GLUCOSE

[0377] 1-O-P-COUMAROYL-b-D-GLUCOSE

[0378] ALLICIN

[0379] ALLIIN

[0380] ALLIOFURÓSIDE-A

[0381] ALLIOSPIRÓSlDE-A

[0382] ALLIOSPIRÓSIDE-B

[0383] ALLIOSPIRÓSIDE-C

[0384] ALLIOSPIRÓSIDE-D

[0385] ALLYL PROPYL SULFIDE

[0386] ALLYL PROPYL TRISULFIDE

[0387] ALLYL-METHYL-DISULFIDE

[0388] ALLYL-METHYL-SULFIDE

[0389] ALLYL-METHYL-TRISULFIDE

[0390] ALLYL-PROPENYL-DISULFIDE

[0391] ALLYL-PROPYL-DISULFIDE

[0392] CAFFÉIC-ACID

[0393] CAMPHESTEROL

[0394] CATECHOL

[0395] CHOLINE

[0396] CIS-PROPENYL PROPYL-DISULFIDE

[0397] CIS-PROPENYL-PROPYL-TRISULFIDE

[0398] CYANIDIN-3-O-LAMINARIBIÓSIDE

[0399] CYANEDIN-3-O-b-D-DIGLYCÓSIDE

[0400] CYANIDIN-BIÓSIDE

[0401] CYANIDIN-DIGLYCÓSIDE

[0402] CYANIDIN-MONOGLYCÓSIDE

[0403] CYCLOALLIIN

[0404] DIALLYL-DISULFIDE

[0405] DIALLYL-SULFIDE

[0406] DIALLYL-TRISULFIDE

[0407] DIHYDROALLIIN

[0408] DIISOPROPYL-TRISULFIDE

[0409] DIMETHYL-DISULFIDE

[0410] DIMETHYL-SULFIDE

[0411] DIMETHYL-TETRASULFIDE

[0412] DIMETHYL-TRISULFIDE

[0413] DIPROPENYL-DISULFIDE

[0414] DIPROPENYL-SULFIDE

[0415] DIEPROPYL-DISULFIDE

[0416] DIPROPYL-TRISULFIDE

[0417] HYDRÓGEN SULFUR

[0418] ISOPROPYL-PROPYL-DISULFIDE

[0419] ISOPROPYL-PROPYL-TRISULFIDE

[0420] KAEMPFEROL-3,4′-DI-O-b-D-GLUCOSIDE

[0421] KAEMPFEROL-4′,7-DI-O-b-D-GLUCOSIDE

[0422] KAEMPFEROL4′-O-b-D-GLUCOSIDE

[0423] LYSINE

[0424] METHIONINE-METHYLSULFONIUM

[0425] METHIONINE-SULFONE

[0426] METHYL-ALLIIN

[0427] METHYL-CIS-PROPENYL-DISULFIDE

[0428] METHYL-METHANOTHIOSULFONIUM

[0429] METHYL-PROPENYL-SULFIDE

[0430] METHYL-PROPENYL-TRISULFIDE

[0431] METHYL-PROPYL-DISULFUIDE

[0432] METHYL-PROPYL-TRISULFIDE

[0433] METHYL-TRANS-PROPENYL-DISULFIDE

[0434] MYRÍSTIC-ACID

[0435] MYROSINASE

[0436] OLEANÓLIC-ACID

[0437] PAEONIDIN-GLYCOSIDE

[0438] PALMÍTIC-ACID

[0439] P-COUMÁRIC-ACID

[0440] PELARGONIDIN-MONOGLYCOSIDE

[0441] PROP-CIS-ENYL-PROPYL-DISULFIDE

[0442] PROP-CIS-ENYL-PROPYL-TRISULFIDE

[0443] PROPENYL-PROPYL-SULFIDE

[0444] PROP-TRANS-ENYL-PROPYL-DISULFIDE

[0445] PROP-TRANS-ENYL-PROPYL-TRISULFIDE

[0446] PROPYL-METHANOTHIOSULFONATE

[0447] PROPYL-PROPANOTHIOSULFONATE

[0448] PROSTAGLANDIN-A-1

[0449] QUERCETIN

[0450] QUERCETIN-3,4′-DI-O-b-D-GLUCÓSIDE

[0451] QUERCETIN-3-O-b-D-GLUCÓSIDE

[0452] QUERCETIN-4′,7-DI-O-b-D-GLUCÓSIDE

[0453] QUERCETIN-4-O-b-D-GLUCÓSIDE

[0454] RUTIN

[0455] S-ALLIL-CYSTEINE

[0456] SAPONIN

[0457] SELENIUM

[0458] SELENO-CYSTEINE

[0459] SELENO-METHIONINE

[0460] SELENO-METHYLSELENOCYSTEINE

[0461] SELENO-METHYL-SELENOMETHIONINE

[0462] SELENÓSEDE

[0463] S-METHYL-CYSTEINE-SULFÓXIDE

[0464] S-PROPYL ENYL-1-ENYL CYSTEINESULFÓXIDE

[0465] S-PROPYL-CYSTEINE-SULFÓXIDE

[0466] SULFUR

[0467] TRANS-PROPENYL-PROPYL-DISULFIDE

[0468] TRANS-PROPENYL-PROPYL-TRISULFIDE

[0469] TRANS-S-(1-PROPENYL)-CYSTEINE-SULFÓXIDE

[0470] a-AMYRIN

[0471] a-SITOSTEROL

[0472] b-SITOSTEROL

[0473] g-GLUTAMYL-LEUCINE

[0474] g-GLUTAMYL-METHIONINE

[0475] g-GLUTAMYL-PHENYLALANINE

[0476] g-GLUTAMYL-PHENYLALANINE-ETHYL-ESTER

[0477] g-GLUTAMYL-S-METHYL-CYSTEINE

[0478] g-L-GLUTAMYL-ARGININE

[0479] g-L-GLUTAMYL-CYSTEINE

[0480] g-L-GLUTAMYL-ISOLEUCINE

[0481] g-L-GLUTAMYL-S-(1-PROPENYL)L-CYSTEINE-SULFÓXIDE

[0482] g-L-GLUTAMYL-S(2-CARBOXY-N-PROPYL)1-CISTEINE

[0483] g-1,GLUTAMYL-S-(2-CARBOXY-b-METHYL-ETHYL)-CYSTEINYL-GLY

[0484] g-L-GLUTAMYL-VALINE

[0485] CYANIDIN-3-MALONYLGLUCÓSIDE

[0486] CYANIDIN-3-MANOLYLAMINARIBIOSIDE

[0487] QUERCETIN-3,4′-O-b-DIGLUCOPYRANOSIDE

[0488] QUERCETIN-3,7,4′-O-b-GLUCOPYRANOSIDE

[0489] QUERCETIN-4′-O-b-GLUCOPYRANOSIDE

[0490] Of these compounds, the following are believed to be the mostlikely candidates to be separately or jointly responsible for themedicinal properties of the subject Allium extracts.

[0491] 1-O-CAFFEOYL-b-D-GLUCOSE

[0492] ALLICIN

[0493] ALLIIN

[0494] ALLYL PROPYL SULFIDE

[0495] ALLYL PROPYL TRISULFIDE

[0496] ALLYL-METHYL-DISULFIDE

[0497] ALLYL-METHYL-SULFIDE

[0498] ALLYL-METHYL-TRISULFIDE

[0499] ALLYL-PROPENYL-DISULFIDE

[0500] ALLYL-PROPYL-DISULFIDE

[0501] CAFFÉIC-ACID

[0502] CATECHOL

[0503] CHOLINE

[0504] DIHYDROALLIN

[0505] KAEMPFEROL-3,4′-DI-O-b-D-GLUCOSIDE

[0506] KAEMPFEROL-4′,7-DI-O-b-D-GLUCOSIDE

[0507] KAEMPFEROL-4′-O-b-D-GLUCOSIDE

[0508] LYSINE

[0509] METHYL-METHANOTHIOSULFONIUM

[0510] OLEANÓLIC-ACID

[0511] PALMÍTIC-ACID

[0512] P-COUMÁRIC-ACID

[0513] PROPYL-METHANOTHIOSULFONATE

[0514] PROPYL-PROPANOTHIOSULFONATE

[0515] QUERCETIN

[0516] QUERCETIN-3,4′-DI-O-b-D-GLUCÓSIDE

[0517] QUERCETIN-3-O-b-D-GLUCÓSIDE

[0518] QUERCETIN-4′,7-DI-O-b-D-GLUCÓSIDE

[0519] QUERCETIN-4-O-b-D-GLUCOSIDE

[0520] RUTIN

[0521] SAPONIN

[0522] SELENIUM

[0523] a-AMYRIN

[0524] a-SITOSTEROL

[0525] b-SITOSTEROL

[0526] CYANIDIN-3-MALONYLGLUCÓSIDE

[0527] CYANIDIN-3-MANOLYLAMINARIBIOSIDE

[0528] QUERCETIN-3,4′-O-b-DIGLUCOPYRANOSIDE

[0529] QUERCETIN-3,7,4′-O-b-GLUCOPYRANOSIDE

[0530] QUERCETIN-4′-O-b-GLUCOPYRANOSIDE

[0531] However, Applicants do not want to be bound by such hypotheses.In fact, it may be that the medicinal properties of the subject Alliumextracts may involve different constituents, or may require a particulardistribution of constituents that are selectively obtained by theafore-described processing procedure. Moreover, as discussed previously,the particulate size or other morphological properties of the materialmay also be significant to medicament activity.

[0532] The particles obtained by the described procedure may beadministered by systemic or non-systemic means. Typically, the particles(in the form of a powder) will be placed in capsules that eitherdissolve in the stomach or intestine, or both, or will be used to maketablets, suppositories, sachets, or will liquid administrable forms,e.g., elixirs, syrups, or suspensions. Alternatively, these powders canbe used to produce an injectable composition, e.g., by addition to apharmaceutically acceptable excipient such as buffered saline. Of thesemodes of administration, oral administration is preferred. For example,in a preferred embodiment, capsules containing the powder according tothe invention may be ingested with an ingestible fluid, e.g., juice,water, or milk. Still alternatively, the powders will be added to afood, e.g. solid or liquid that camouflages the taste of the particles,especially if the user does not like the taste of onion.

[0533] Methods for producing orally administrable materials havingdesired properties, e.g., sustained or rapid release, enteric-coatedforms, are well known and are described in Remington's PharmaceuticalSciences, Mack Publishers (incorporated by reference herein.)

[0534] In producing capsules, the subject Allium powder may be combinedwith other materials, if desired, e.g, sugars such as lactose, sucrose,mannitol, starches, cellulose derivatives, magnesium stearate or stearicacid. Also, materials that enhance aesthetic properties of the materialmay be added, e.g., colorants and flavoring materials. Additives whichcan be utilized in capsule formulations are well known to those skilledin the art.

[0535] If the subject powders are utilized to make tablets, conventionaltableting procedures can be used which typically comprise processing thematerials by compression to produce a tablet. Materials which facilitatetablet formation can be utilized, e.g., binders and bulking agents orother additives, including by way of example gums, waxes, insolublepolymers, polyvinyl alcohol, polyethylene glycol, sucrose, lactose,acacin, tragacanth, and polyvinyl pyrrolidine. Also, additives may beutilized which enhance taste and appearance, e.g., flavoring or coloringagents.

[0536] In a preferred embodiment, the tablets are coated such that theyare selectively released in the stomach or intestine. With respectthereto, coatings which are acid-stable and allow for drug release inthe intestine (referred to generally as enteric coatings) are wellknown. Examples include shellac and derivatives thereof, celluloseacetate phthalate, hydroxypropyl/methylcellulose phthalate, ethylcellulose. Such enteric coating and methods for application thereof arediscussed in detail in Remington's Pharmaceutical Sciences, (Id.) Also,U.S. Pat. Nos 4,017,647 and 4,287,221 are exemplary of enteric coateddrug formulations. The enteric coated form should enhance theantimicrobial properties of the powder.

[0537] Alternatively, and preferably in the case of subjects that findsolid dosage formulations difficult to take (which may be a significantconcern in AIDS patients who at latter stages may have swallowingproblems), the subject materials may be produced in the form of liquidelixirs, or other liquids. This can be effected by combining the subjectAllium powder with fruit or other vegetable juices, sugars, flavoringmaterials, or other materials having known application in liquid drugformulations. This is further advantageous for subjects that find thetaste of the subject material disagreeable. Still alternatively, thesubject material may be combined with solid foods, e.g., in order tocamouflage the taste, if desired.

[0538] As noted, a less preferred means of administration will compriseinjectable formulations. In this embodiment, the powder will be combinedwith an injectable liquid, e.g., buffered saline, and injected by knownroutes, e.g., intravenous, intramuscular, intradermal, or subcutaneousroutes of administration. For example, a subject with an AIDS-associatedlesion may be injected at the site of lesion to elicit an immunemodulating or T-cell response.

[0539] Other modes of administration include topical, inhalatory,intranasal, sustained release implants, and rectal or vaginalsuppositories.

[0540] The amount of particles which are administered, e.g., orally,injection, suppository, intranasal, will typically range from about 5-50grams per day, and more preferably about 9 to 13 grams per day. Aparticular advantage of the medicament of the present invention is thatthere are no known side effects. Consequently, there are no real upperdosage ranges.

[0541] A general description of properties of the subject material issummarized below.

[0542] 1. Description of the Medicinal Allium Product of the Invention

[0543] Properties of the medicinal product of the invention wereevaluated by placing 10 grams of this material in 500 ml of boiled waterand heated for 10 minutes. The rehydrated vegetable exhibited thefollowing characteristics: Look & Color Flavor Aroma White flakes withsome green particles Characteristic Characteristic

[0544] 2. Granulometric Retained on sieve USA 3/8 (9.5 mm)  5% maxRetained on sieve USA 8 (2.36 mm) 99% min Through sieve USA 8  5% max

[0545] 3. Humidity

[0546] Max 5.5%

[0547] 4. Microbiological Analysis Total Aerobic Mesophiles 300,000ufc/g Maximum Total Coliforms 1,000 NMP/g Maximum E. coli NegativeReduce sulphite Clostridium 10 ufc/g Maximum Yeast and Molds 1,000 ufc/gMaximum

[0548] As noted above, the subject materials can be stored for prolongedperiods prior to usage, preferably by storing in a dry, ambienttemperature conditions, i.e., about 18-25° C., preferably in the dark toavoid oxidation. Preferably, the material will be stored in a sealedplastic bag or other container to maintain low humidity and avoidmicrobial or other contamination.

[0549] As discussed previously, the subject medicament has a number ofdifferent properties that render it well suited for use as atherapeutic. For example, it has been found that the subject Alliumderived medicament has broad antiviral activity. The subject extract maybe used to treat or prevent a variety of different viral infections,both human and animal viruses. Examples thereof include retroviralinfections such as AIDS, herpes (genital, rectal, oral), distemper,papillomavirus, flu associated influenza viruses, parvoviruses,rhabdoviruses, Epstein Barr virus, CMV, hepatitis virus, RSV,rhinoviruses, and foot and mouth disease virus.

[0550] In the preferred embodiment, the subject Allium derivedmedicament will be used for the treatment of AIDS. Entirelyunexpectedly, it has been found that administration of the subjectmedicament to patients with AIDS results in disappearance of eliminationof the clinical symptoms associated therewith, such as wasting syndrome,paresthesia intestinal colic, diarrhea, polyadenopathy, and HIV relatedinfections. To date, these results have been observed in eight differentpatients having an age ranging from 28 to 38, many of which were in thelatter terminal (“C-stage”) of AIDS. These clinical results aresummarized in the example infra.

[0551] In effecting the HIV treatment protocol of the invention,patients with AIDS will be withdrawn~from anti-AIDS conventionalmedications such as protease inhibitors, anti-retrovirals, cytotoxicdrugs, steroids, chemotherapies, and preferably will be placed on arestricted diet developed by the inventors. The use of tobacco and othersmoking products or narcotics is also forbidden.

[0552] This diet preferably comprises ingestion of only natural products(without preservatives, and chemical additives) such as vegetables,fruits, fish, meat in small quantities, no fried foods, no alcoholicbeverages, no caffeinated beverages such as coffee, tea, and nosweetened drinks such as sodas. The use of tobacco and other smokingproducts, or narcotics, is also forbidden. If intestinal irregularitiesresult because of ingestion of large amounts of vegetables and fruit,this preferably will be treated by ingestion of rice, white bread,cheese, apples or lemon. However, if necessary an anti-diarrheicmedicine may be administered. Moreover, if significant weight lossresults, then unfried potatoes, preferably about 250 grams twice a daymay be ingested.

[0553] The subject AIDS therapy will comprise administration, preferablyabout 9-13 g/day of the subject medicament. Preferably, this will beeffected orally, e.g., in capsule form by mixing in a suitable beverageor with food. However, other known modes of administration can be used.This treatment should be continued for the life of the patient. Amaintenance dose is established once the patient is free of symptoms.This maintenance dosage typically will range from about 5-7 g/day. Infact, it has been observed for some patients who have stopped thistreatment, that AIDS symptoms have relapsed. However, when thesepatients resumed the subject treatment, remission (absence of clinicalsymptoms) again resulted. Ideally, the treated patients will alsoundergo an exercise regimen/regime to help enhance overall wellness.

[0554] Also, the subject medicament may be used to treat otherconditions. In particular, the subject medicament may be used tomodulate the immune system, stimulate the immune system, and/or enhanceT cell function and/or proliferation in subjects in need of suchtreatment. Examples where such treatment will be of therapeutic benefitinclude boosting the immune systems of aged or immunosuppressed persons,persons with cancer, and persons with infection. In particular, thesubject medicament has application in treatment and/or prevention ofmicrobial infection, e.g., by fungi.

[0555] Still further, the subject medicament may be used to induceweight gain in persons in need of such treatment, e.g., those sufferingfrom anorexia.

[0556] These treatments will be effected substantially the same as AIDStreatment, i.e., an effective amount of the subject Allium cepa materialwill be administered, preferably by oral administration, typically adaily dosage of about 9-13 g/day or more.

[0557] Also, the subject medicament may be used to treat infections,e.g., viral or bacterial infections, in animals such as dogs, cats, andbirds. In fact, the means by which the subject medicament was initiallyshown to be effective involved treatment of a dog with parvovirusinfection. As with AIDS treatment, this treatment has been observed tototally eradicate the clinical symptoms of the disease in the treatedanimal. Other animal diseases which have been treated include distemper,and psittacosis.

[0558] Still other diseases and conditions treatable with the subjectAllium extract include candidiasis, e.g. pneumonia, caused byPneumocistis carinii, urinary infection, and mycosis.

EXAMPLE

[0559]Allium cepa extracts produced according to the invention wereorally administered to eight persons that are HIV⁺, most of them withfull blown AIDS. In fact, some of these persons were close to death whentreatment initiated. Treatment comprised stopping conventionaltreatment, starting of the dietary regimen according to the invention,and oral ingestion of about 9 to 13 g/day of the subject Allium extractdaily. As can be seen from the results in the Table below, dramaticresults were achieved, i.e., all of these eight persons had a totalremission of clinical symptoms associated with AIDS and were able toresume a normal life style after treatment. CLINICAL CHARACTERISTICS OFPATIENTS WITH HIV INFECTION TREATED WITH IMMUNO-PLUS AND DIETARY REGIMENPATIENT No. 103* 105 101 109 108 106* 107* 102* AGE 38 28 32 34 29 31 3030 SEX M M M M M M M M TE HIV DIAGNOSIS 1991 1994 1994 1993 1993 19961994 1997 CDC CATEGORY C.2 C.2 C.2 B 1 A.1 C.1 B 1 C.3 STARTING DATESep. 1, 1997 Jun. 26, 1997 Jun. 24, 1997 Jun. 4, 1993 Oct. 6, 1993 Mar.25, 1996 Jan. 28, 1994 Nov. 10, 1997 PREVIOUS ANTIBIOTICS ANTIBIOTICS,NO NO NO NO ANTIBIOTICS SUSPENDED MEDICATION (BACTRIM) ANTIMICOTICS,(BACTRIM) ANTIRETROVIRALS ANTACIDS 8 DAYS AGO ADENOPATHY INGUINIAL NOOCCIPITAL, POLYADE- NO ADENOPATHY, CERVICAL- POLYADENOPATHTY BILATERIALCERVICAL NOPATHY CERVICAL, ARMPIT ARMPIT LEFT ARMPIT BILATERALCONSTITUTIONAL <WEIGHT, 39° C. <WEIGHT, <7 KG 90 <WEIGHT NO <4 KG-6 MO.<4 KG-CONT. <18 KG-6 MONTHS SYNDROME INTESTINAL DAYS, INTERMIT. UP FEVERINTERMIT. DIARRHEA, DIARRHEA, CONT DIARRHEA, DIARRHEA, TO 38° C. FEVERFEVER FEVER 38° C. 38° C. PERSISTENT HISTORY OF HIV ORAL/RECTAL ORALHERPES, ORAL ORAL HERPES, NO NO PNEUMONIAS PNEUMONIAS RECTAL HERPES,RATED INFECTIONS HERPES, MICOSIS, PNEUMONIAS PNEUMONIA SIGMOIDITIS, OROF ARINGEAL PNEUMONIAS, MICOSIS, URINARY PNEUMONIA INFECTIONSGASTRO-INTESTINAL EPIGASTRALGIA, NAUSEA, ANOREXIA, INTERMIT. NO NOANOREXIA ANOREXIA INTESTINAL COLICS, SYMPTOMS ANOREXIA, INTESTINALCOLICS DIARRHEA, INTESTINAL DIARRHEA, INTESTINAL COLICS PERFORATION ANDINTESTINAL SURGERY ON Oct. 1997 COLICS OTHER CLINICAL PARESTHESIAS OFSEVERE SHORTNESS DEPRESSION, DEPRESSION, NO GASTRITIS, ANOREXIA TREATEDIN — OPENED INFECTED ASPECTS LOWER LIMBS, OF BREATH, OXYGEN GENERALSUBMAXIL- BUENOS AIRES SURGERY WOUND, DEPRESSION, THERAPY, RESERVEDDISCOMFORT, LARY FOR EMACIATION, RIGHT ORCHITIS PROGNOSIS ANXIETYABSCESS PNEUMONIAS DYSPNEA III-IV, TERMINAL PATIENT EVOLUTION GAINED 4KG, NO <WEIGHT, PHYSICAL PHYSICAL PHYSICAL PHYSICAL PHYSICAL EXAMINATIONPHYSICAL >14 KG TO DATE, JAN-FEB '98 INFECTIOUS SYMP- EXAMINATIONEXAMINATION EXAMINA- EXAMINA- NORMAL EXAMINATION PALENESS, TOMATOLOGY,NORMAL NORMAL TION TION NORMAL WEAKNESS, GOOD GOOD GENERAL NORMAL NORMALPROGRESS CONDITION EVOLUTION ALL PATIENTS ARE CURRENTLY IN GOODCONDITION, PHYSICAL EXAM NORMAL (**) DECEMBER '99

What is claimed is:
 1. A method for treating an HIV positive or AIDSpatient comprising administering a therapeutically effective amount of aplant extract derived from an Allium species other than A. sativum,wherein said plant extract is obtained from a dehydrated Allium plantmaterial that is processed after dehydration to produce particles havingan average particle size ranging from about 1 to 1,400 microns.
 2. Themethod of claim 1, wherein said Allium plant extract is administeredorally.
 3. The method of claim 1, wherein said Allium plant extract isproduced from an Allium selected from the group consisting of A. cepa,A. ampeloprasum, A. fistulosa, and A. schoenoprasum.
 4. The method ofclaim 3, wherein said Allium is A. cepa.
 5. The method of claim 1, whichcomprises daily administration of about 1 to 50 grams of saidparticulate Allium plant extract.
 6. The method of claim 1, whichlengthens the latent phase of AIDS.
 7. The method of claim 1, whichresults in alleviation, improvement, or eradication of wasting syndrome,or other clinical symptoms associated with AIDS or HIV⁺ patients.
 8. Amethod for treating or preventing viral infection in a patient in needof such treatment or prevention comprising administering atherapeutically or prophylactically effective amount of a plant extractis obtained from a dehydrated Allium plant material that is processedafter dehydration to produce particles having an average particle sizeranging from about 1 to 1,400 microns.
 9. The method of claim 8, whereinsaid Allium extract is administered orally.
 10. The method of claim 8,wherein said viral infection is selected from the group consisting ofinfluenza, herpes, hepatitis, parvovirus, distemper, RSV, CMV,rhinovirus, rhabdovirus, papillomavirus, Epstein Barr, and foot andmouth disease virus.
 11. The method of claim 8, wherein said Allium isselected from the group consisting of A. cepa, A. ampeloprasum, A.fistulosa, and A. schoenoprasum.
 12. The method of claim 9, wherein saidAllium is A. cepa.
 13. The method of claim 8, wherein said particulateextract is administered orally.
 14. The method of claim 1, wherein saidparticulate extract is administered orally.
 15. A method for promotingappetite and/or weight gain in a patient in need of such treatment,comprising administering an effective amount of a plant extract derivedfrom an Allium species other than A. sativum, wherein said plant extractis obtained from a dehydrated Allium plant material that is processedafter dehydration to produce particles having an average particle sizeranging from about 1 to 1,400 microns.
 16. A method for stimulatingand/or modulating the immune system of a subject in need of suchtreatment comprising administering an immunostimulating and/orimmuno-modulating effect amount of a plant extract derived from anAllium species other than A. sativum, which extract is obtained from adehydrated Allium plant material that is processed after dehydration toproduce particles having an average particle size ranging from about 1to 1,400 microns.
 17. The method of claim 1, which is used to boost theimmune system of a subject having an immune system that is compromisedby age, disease, and/or inadequate nutrition.
 18. The method of claim16, wherein said Allium is-selected from the group consisting of A.cepa, A. ampeloprasum, A. fistulosa, and A. schoenoprasum.
 19. A methodfor enhancing T-cell function, proliferation and/or differentiation in asubject in need of such treatment comprising administering an effectiveamount of a plant extract derived from an Allium species other than A.sativum, wherein said extract is obtained from a dehydrated Allium plantmaterial that is processed after dehydration to produce particles havingan average particle size ranging from about 1 to 1,400 microns.
 20. Amethod for treating microbial infection in a subject in need of suchtreatment comprising administering an effective amount of a plantextract derived from an Allium species other than A. sativum, whichextract is obtained from a dehydrated Allium plant material that isprocessed after dehydration to produce particles having an averageparticle size ranging from about 1 to 1,400 microns.
 21. The method ofclaim 20, which is used to treat yeast infection.
 22. The method ofclaim 20, which is used to treat fungal infection.
 23. The method ofclaim 20, wherein said Allium is selected from the group consisting ofA. cepa, A. ampeloprasum, A. fistulosa, and A. schoenoprasum.
 24. Themethod of claim 23, wherein said Allium extract is derived from A. cepa.25. The method of claim 1, which further comprises placing said patienton a restricted diet.
 26. The method of claim 1, wherein said patient isnot being treated with any other anti-AIDS therapeutics.
 27. A methodfor producing an Allium plant extract having antiviral, antimicrobialand/or immuno-modulating properties comprising the following steps: (1)obtaining an Allium plant material which includes at least the bulbportion of the plant, wherein said Allium is of a species other than A.sativum; (2) subjecting said plant material to one or more washingprocedures, wherein washing is effected using a chlorinated aqueoussolution; (3) dehydrating said washed Allium plant material by heatingat a temperature ranging from about 80° to 110° C.; and (4) processingsaid dehydrated Allium plant material under low humidity to produce acomposition comprised of particles wherein the average particle sizeranges from about 1 to 1,400 microns.
 28. The method of claim 27,wherein the washed plant material is cut into thin slices prior todehydration.
 29. The method of claim 27, wherein the particulatecomposition resulting from step (4) is placed into capsules.
 30. Themethod of claim 27, wherein the particulate composition resulting fromstep (4) is used to produce suppositories tablets, or sachets.
 31. Themethod of claim 27, wherein the particulate composition resulting fromstep (4) is used to produce a liquid orally administrable formulation.32. The method of claim 29, wherein said tablets are coated such thatthey dissolve selectively in the stomach or intestine, or comprise amixture of coated tablets that dissolve selectively in the stomach andintestine.
 33. A medicinal extract derived from an Allium species otherthan A. sativum produced according to claim
 27. 34. The medicinalextract of claim 33, which is obtained from A. cepa.
 35. The medicinalextract of claim 33, which is in the form of a powder, capsule, tabletsuppository, sachet, injectable composition, oral administrable liquid,inhalatory, aerosol, or topically administrable composition.
 36. Themedicinal extract of claim 35, which comprises a tablet.
 37. Themedicinal extract of claim 35, which comprises a capsule.
 38. Themedicinal extract of claim 35, which comprises a suppository.